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Timely Consult and Early Information Request (TCIR) Process for Drug Master Files (DMFs)
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FDA discusses background and data on the TCIR process for DMFs, which could have a substantial impact on the overall ANDA approval process.
Presenter: Jayani Perera, Division of Lifecycle API, Office of Pharmaceutical Quality
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Phone - (301) 796-6707 I (866) 405-5367
Presenter: Jayani Perera, Division of Lifecycle API, Office of Pharmaceutical Quality
--------------------
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Phone - (301) 796-6707 I (866) 405-5367
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